Participants Enrolled in Antecedent RTX001 Liver studies (PEARL) v1.0
Research type
Research Study
Full title
Long-term Follow-up Study of Participants Enrolled in an Antecedent Study to Evaluate RTX001 as an Autologous Regenerative Macrophage Therapy for Decompensated Liver Cirrhosis
IRAS ID
355636
Contact name
Jonathan Fallowfield
Contact email
Sponsor organisation
Resolution Therapeutics
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
The aim of this observational study is to follow the progression of patients who have liver cirrhosis and who have previously taken part in an earlier study (as either a control patient or received study treatment) to evaluate the effects of a study treatment (RTX001) for liver cirrhosis. The purpose of this new study is to find out how safe and how well the study treatment (RTX001) works over a longer period of time.
This study does not involve taking any study medication or require patients to come to the clinic for any extra visits. The study will follow patients ongoing routine medical care and does not require any additional tests or investigations other than what they would need to have as part of their ongoing routine care for liver cirrhosis.
Data to monitor progress of liver disease will be collected during the study by reviewing patient electronic medical records/notes. This will involve a member of the local research team looking through the patients’ medical records to collect certain information. This information will already be noted in the patients medical records as part of usual care and treatment. Data will be collected by the site team every 6 months for up to 3 years.
If a patient has not attended for medical review as part of their usual care during the last six months from when the data is being collected, a member of the local research team will phone the patient to check they are still receiving ongoing medical care for their liver disease. If a patient receives a liver transplant or no longer wishes to take part in the study, then no further information will be collected.
Overall, this study will provide a deeper understanding of the safety and effectiveness of a potential new treatment for liver disease.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/PR/0431
Date of REC Opinion
25 Apr 2025
REC opinion
Unfavourable Opinion